药学研制现场核查的问题分析和建议
Analysis and suggestions on on-site verification of pharmaceutical development
宋波 1黄莺 1周萌萌 1胡小娟 1石娟 1郑啸 1翟铁伟1
作者信息
- 1. 国家药品监督管理局 食品药品审核查验中心,北京 100044
- 折叠
摘要
药学研制现场核查主要是对药学研制情况开展的核查工作.近年来药品注册研制现场核查发现,药学研制阶段存在诸多问题,如真实性、一致性、数据可靠性、技术转移问题,因此建议药品研制单位进行规范性建设,建立与研制行为相匹配的质量管理体系,加强数据可靠性管理,构建完善的技术转移过程.分析了药学研制现场核查的问题,提出建议,希望为药学研制工作规范化提供参考.
Abstract
The on-site verification of pharmaceutical research mainly verifies the status of pharmaceutical research work.In recent years,on-site inspections of drug registration and development have found that there are many problems with authenticity,consistency,data reliability,and technology transfer in the pharmaceutical development stage.Therefore,it is recommended that drug development enterprises carry out standardized construction,establish a quality management system that matches their research and development behavior,strengthen data reliability management,and build a sound technology transfer process.This article analyzes the problems of on-site verification in pharmaceutical development and proposes suggestions,hoping to provide reference for the standardization of pharmaceutical development work.
关键词
药学研制现场核查/真实性/一致性/数据可靠性/技术转移/质量管理体系Key words
on-site verification of pharmaceutical development/authenticity/consistency/data reliability/technology transfer/quality management system引用本文复制引用
出版年
2024
NETL
NSTL
万方数据